Built by a cell therapy coordinator

The team operating system for cell and gene therapy programs

Zen Cell and Gene is a standalone web app that pulls patient cohort data from Epic and gives cell therapy teams a shared roster, dynamic per-patient care paths, cohort calendar, and AI-assisted coordination across the full CGT journey, from referral through long-term FDA-mandated follow-up.

Cell therapy teams operate clinically as a team but operationally as individuals

Every coordinator runs their own scattered system: spreadsheets, REMS portals, manufacturer portals, email threads, and side notes. The patient data is in Epic. The operational state of the program lives in individual heads.

When a coordinator is out, coverage falls apart. Onboarding takes months. Continuity depends on individual memory. The team has no shared operational substrate. That is the load-bearing dysfunction Zen Cell and Gene fixes.

5+
REMS and manufacturer portals per program, one per commercial product
15 yr
FDA-mandated long-term follow-up for some cell and gene therapies
2x
CAR-T treatment volume growth every three years, with flat coordinator headcount
1
Coordinator-owned spreadsheet still holding most programs together

Built for cell and gene therapy, integrated with Epic

Epic owns the chart, encounter, MAR, billing, e-prescribing, and ambient transcription. We own the multi-patient cohort workbench that does not exist today. Every architectural choice reflects that boundary.

Cell-therapy-first data model

Schema reflects CGT complexity natively: REMS programs, mobilization, conditioning, manufacturing logistics, engraftment, surveillance, and FDA-mandated long-term follow-up. Not a generic oncology layer with cell therapy bolted on.

Epic integration, not Epic replacement

Pulls patient cohort data from Epic via SMART Backend Services and FHIR Bulk Data. Layers cell-therapy-specific operational structure on top. Phase 2 adds CDS Hooks, SMART app launch, and FHIR write-back.

AI-native, not AI-added

The Cell Therapy Chart Monitor (patent pending) is a persistent per-patient context window across the entire CGT journey. It surfaces relevant facts at every decision moment, drafts notes, and anticipates next steps.

Team workspace, not individual tool

Coordinators, program directors, APPs, and nursing leadership share one operational substrate. Role-based views, task assignment, shared annotations, and an audit trail. No more handoff binders or coverage chaos.

HIPAA-compliant by design

Multi-tenant from day one with MFA, session management, audit logging, RBAC, PHI tokenization, and consent management baked in. SOC 2 Type II on the roadmap. Designed to clear academic medical center procurement.

FACT and REMS aware

Structured outcomes capture aligned to FACT accreditation requirements. REMS data fields tracked alongside the chart so end-of-cycle reporting is a query, not a manual rebuild from notes and emails.

The shared operational substrate cell therapy programs do not have today

From referral and pre-apheresis through infusion, engraftment, and long-term follow-up.

The Roster

Single-screen view of every cell therapy patient under the program's care. Stage, product, key milestones, and next-action surface. Color-coded, sortable, filterable. Replaces the master spreadsheet.

Dynamic per-patient care path

Auto-generated timeline from the patient's product (Yescarta, Kymriah, Breyanzi, Abecma, Carvykti, MM Auto-SCT with Mel200, etc.) showing every milestone from referral through 5-year surveillance. Adapts when reality deviates from template.

Cohort calendar

What is happening across all patients this week and this month. Apheresis, conditioning starts, infusion, milestone visits, REMS deadlines, manufacturing slots.

Cell Therapy Chart Monitor

Patent-pending per-patient AI context window across the entire CGT journey. Status auto-updates from FHIR ingestion. Proactive risk surfacing. Care path deviation detection. Drafting assistance for notes, letters, and REMS data entry.

Granular state tracking

Per-patient capture of manufacturing slot, apheresis date, conditioning regimen, infusion date, CRS and ICANS grades, and response assessments. Structured data, not free text.

Mobilization workflow

CD34-driven dynamic apheresis scheduling with plerixafor rescue logic for Auto-SCT. A genuinely net-new workflow primitive that no general oncology system handles well today.

Team coordination

Task assignment, shared annotations, role-based views for coordinators, program directors, APPs, nursing, and social work. Full audit trail. Conversational queries via the agent framework.

FHIR ingestion from Epic

Auto-pull labs, vitals, encounters, medications, allergies, conditions, and demographics. The coordinator never dual-enters. Built on FHIR R4 with SMART Backend Services from day one.

MVP coverage: commercial CAR-T (Yescarta, Kymriah, Breyanzi, Abecma, Carvykti) plus selected trial CAR-T products, and Multiple Myeloma Auto-SCT with Mel200 conditioning. NHL and Hodgkin Auto-SCT (BEAM) follow in V1.5. Gene therapy care paths (Casgevy, Lyfgenia, Hemgenix, Beqvez, Elevidys, Luxturna, Zolgensma, Roctavian) and allogeneic SCT in V2.

Built from the bedside

Zen Cell and Gene is built by Jake Cotner, a Cell Therapy RN Coordinator working on the front lines at an academic cancer center. The product is grounded in lived experience navigating the gaps in existing systems while coordinating some of the most complex treatments in medicine.

Cell therapy teams operate clinically as a team but operationally as individuals. Every coordinator runs their own scattered stack of spreadsheets, portals, and email threads. When that coordinator is out, coverage falls apart. The product fixes the load-bearing dysfunction: programs need a shared operational substrate, and Epic does not provide one.

Let's talk

If you run a cell therapy program, want to discuss a pilot, or want to understand the architecture in more depth, send a note. Replies come from Jake directly.

Prefer email? jake@zenhealthsystems.com